EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared May 2017
Total Reports
1,518
Reports (30d)
2
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Severe Stenosis and Heart Failure Symptoms
ultra, specialist, sapien ultra, resilia valve, ultra resilia
16
reports
Valve Explantation Four Years Post-Implant
aortic position, registry, sapien ultra, months, explanted
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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